MONOCLONAL ANTIBODIES – The Development of Therapeutic Monoclonal Antibody Products: A Comprehensive Guide to CMC Activities From Clone to Clinic
Howard L. Levine, PhD, and Brendan R. Cooney, provide a guide to product development companies, service providers, investors, and analyst as they work their way through the complex and rapidly evolving world of therapeutic monoclonal antibodies.
EXECUTIVE INTERVIEW – MilliporeSigma: Accelerating the Development & Manufacture of Gene Therapies, Immunotherapies & Viral Vaccines
Dave Backer, Head of Virus & Gene Therapy Strategic Initiatives at MilliporeSigma, talks about his company’s expanding GMP capacity to speed development and manufacture of gene therapies, immunotherapies, and viral vaccines.
Contributor Cindy H. Dubin explores 3D printed drugs in the wake of a milestone in the pharma industry when Aprecia Pharmaceuticals’ Spritam (levetiracetam) tablets became the first FDA-approved prescription drug product manufactured using 3D printing technology.
Peter Nielsen, MBA, explains how his company’s candidates are differentiated from those in development at other companies by the type of modification to the antisense molecule and the method by which it is conveyed to its target cell.
EXECUTIVE INTERVIEW – NanOlogy: Submicron Particle Platform Transforms Systemic Chemotherapy Into Local Delivery
Marc Iacobucci, Managing Director of NanOlogy, discusses his company’s technology, clinical program, and efforts to transform cancer therapy.
Contributor Cindy H. Dubin speaks with several innovative companies on their science, techniques, and technologies aimed at improving bioavailability and solubility.
Susan Rosenbaum, JD, and Irwin Hollander, PhD, present a unique and novel solution to this greatest challenge in medicine for brain disease treatment, considered the “Holy Grail of Neuroscience,” with their breakthrough innovation.
Thomas Del’Guidice, PhD, Nancy Messier, PhD, and David Guay, PhD, present the Feldan Shuttle technology, a peptide-based delivery method that could provide efficient and safe intrabody delivery in mammalian cells.
GENE-EDITING TECHNOLOGY – How CRISPR-Cas9 Technology Will Play a Vital Role in the Future of Human Therapeutics & Drug Discovery
Kevin Holden, PhD, explores how this technology can be utilized in research efforts toward the development of new therapies and how it will play a vital role in the future of biopharma and drug discovery.
Omid Vafa, PhD, MBA, reviews unique technologies, including a transgenic rat platform expressing human heavy chain antibodies, and a state-of-the-art sequence-based discovery engine, to create novel multispecific antibodies for various therapeutic indications.
EXCLUSIVE ONLINE CONTENT
Kymab & LifeArc Enter Strategic Partnership to Discover New Medicines Using Kymab’s IntelliSelect Technologies
The agreement will enable LifeArc to enhance its antibody drug discovery capabilities into new medicinal products with Kymab’s proprietary IntelliSelect technology platforms.
Loxo Oncology, Inc. recently entered into a strategic partnership agreement with Amoy Diagnostics Co., Ltd. and PREMIA Holdings (HK) Ltd.
Aclaris Therapeutics, Inc. recently announced positive results from a Phase 2 open-label clinical trial of ATI-502 (AGA-201), an investigational topical Janus Kinase (JAK) 1/3 inhibitor, in patients with androgenetic alopecia (AGA), a condition commonly known as male/female-pattern baldness.
Gilead Sciences, Inc. and Nurix Therapeutics, Inc. recently announced a global strategic collaboration to discover, develop, and commercialize a pipeline of innovative targeted protein degradation drugs for patients with cancer and other challenging diseases.
Array BioPharma Acquisition Will Accelerate Pfizer’s Position as a Major Player in Colorectal Cancer
Following the news that Pfizer has agreed to acquire Array BioPharma in a deal worth approximately $11.4 billion, Tajekesa Chapman, PhD, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers her view on the potential of this buy-out on the treatment of colorectal cancers.